FDA Drug recall D-0474-2017
Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400…
- FDA Drug
- Class II
- terminated
- Published 2017-02-22
On 2017-02-22 the FDA classified a Class II recall of Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400… by Aurobindo Pharma Usa, citing failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0474-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-22 |
| Published | 2017-02-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Aurobindo Pharma Usa |
| Distribution | US |
Product
Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 072 India, NDC 65862-527-30
Reason
Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
Identifiers
| ndc | 65862-527-47 |
|---|---|
| ndc | 65862-527-30 |
| ndc | 65862-527-90 |
| ndc | 65862-527-01 |
| ndc | 65862-527-99 |
| ndc | 65862-527-59 |
| ndc | 65862-527-10 |
| ndc | 65862-528-47 |
| ndc | 65862-528-30 |
| ndc | 65862-528-90 |
| ndc | 65862-528-01 |
| ndc | 65862-528-99 |
| ndc | 65862-528-35 |
| ndc | 65862-528-10 |
| ndc | 65862-697-47 |
| ndc | 65862-697-30 |
| ndc | 65862-697-90 |
| ndc | 65862-697-01 |
| ndc | 65862-697-05 |
| ndc | 65862-697-26 |
| ndc | 65862-697-10 |
| code_info | Lot #: VI3716010-A, Exp. 04/2018 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0474-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.